A Safety and Immunogenicity Study of Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in Preadolescents and Adolescents (Base Study). A Long Term Immunogenicity, Safety, and Effectiveness Study of GARDASIL (Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) Among Adolescents Who Received GARDASIL at 9-18 Years of Age (Extension Study).

Trial Information

A Safety and Immunogenicity Study of Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in Preadolescents and Adolescents (Base Study). A Long Term Immunogenicity, Safety, and Effectiveness Study of GARDASIL (Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) Among Adolescents Who Received GARDASIL at 9-18 Years of Age (Extension Study).

The original base protocol (V501-018)(NCT00092547) was extended in amendments 05 and 06 to
provide 37 months of follow-up. Additionally, subjects in the Placebo Group during the base
study were given 3 doses of open-label GARDASIL™ (V501) at Months 30, 32, and 36.

The study was extended again in amendment V501-018-10(NCT00092547), titled "A Long Term
Immunogenicity, Safety, and Effectiveness Study of GARDASIL (Human Papillomavirus [Types 6,
11, 16, 18] Recombinant Vaccine) Among Adolescents Who Received GARDASIL at 9-18 Years of
Age" to allow a follow-up period to Month 126.

Inclusion Criteria:

- Healthy adolescents and preadolescents with no prior sexual history

Exclusion Criteria:

- Subjects with compromised immune system or have a history of severe allergic reaction

Study Design:

Outcome Measure:

Number of Participants Reporting Serious Adverse Experiences (SAE) in the Vaccination and Follow-up Phases

Outcome Description:

Tolerability as assessed by the number of participants with clinical adverse experiences in the Vaccination and Follow-up Phases.
A serious adverse event is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgment.

Outcome Time Frame:

Day 1 through Month 18

Safety Issue:

Yes

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Merck

Authority:

United States: Food and Drug Administration

Study ID:

V501-018

NCT ID:

NCT00092547

Start Date:

October 2003

Completion Date:

November 2014

Related Keywords:

Healthy Papillomavirus Infections

Papillomavirus Infections

Name

Location

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